Can inhaled steroids help newborns breathe easier after meconium aspiration?
NCT ID NCT07763119
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This trial tests whether giving an inhaled steroid (budesonide) to newborns with meconium aspiration syndrome can speed up their recovery. Meconium aspiration happens when a baby breathes in a mixture of meconium and amniotic fluid during birth, causing lung inflammation and breathing trouble. The study will compare babies receiving the steroid plus standard care against those receiving a placebo (saline) plus standard care, measuring how quickly they recover, need for oxygen or a breathing machine, and length of hospital stay.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nebulised budesonide (an inhaled corticosteroid) given alongside standard care
- What this could lead to
- If effective, this could offer a simple, targeted way to reduce lung inflammation in newborns with meconium aspiration, potentially shortening hospital stays and improving recovery.
- What could go wrong
- This is a small, single-center trial, and results may not apply broadly. The steroid may not improve outcomes over standard care, and potential risks include local irritation or systemic effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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60 people
The number who actually took part.
- Started
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Nov 2025
- Finished
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Apr 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 to 28 days
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Neonates diagnosed with meconium aspiration syndrome. * Term or post-term neonates. * Admission to the Neonatal Intensive Care Unit (NICU) requiring treatment for meconium aspiration syndrome. * Written informed consent obtained from a parent or legal guardian. Exclusion Criteria: * Major congenital anomalies. * Congenital heart disease. * Respiratory distress due to causes other than meconium aspiration syndrome. * Previous corticosteroid therapy before enrollment. * Neonates meeting any other exclusion criteria specified in the approved study protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Khyber Teaching Hospital Peshawar
Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan
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